ACTRN12611000972921已完成2 期
An Investigator-Initiated Phase 2, Single Centre, Double-Blind, Randomised, Controlled Trial of the Effect of Adalimumab Upon Endothelial Function in Patients with Early and Established Anti-CCP Antibody Positive Rheumatoid Arthritis.
A/Prof Stephen Oakley0 个研究点目标入组 60 人开始时间: 2011年9月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Group 1: Early Rheumatoid Arthritis: Anti-CCP (ACPA) positive rheumatoid arthritis of less than 1 year duration by onset of symptoms, age over 18 years, CRP > 15 mg/L or DAS28-CRP>3.20 within 1 week of enrolment.
- •Group 2: Established Rheumatoid Arthritis: Anti-CCP (ACPA) positive rheumatoid arthritis of greater than 1 year duration by onset of symptoms, age over 18 years, CRP>15 mg/L or DAS28-CRP>3.20 within one month of enrolment
排除标准
- •1. Disease Remission (ACR / EULAR 2010 Criteria) or CRP<15 mg/L
- •2. Anti-CCP antibody test negative
- •3. Serious malignancy within the last 5 years
- •4. Demyelinating Disease
- •5. Evidence of previous untreated TB infection
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